The Effect of Robot Assisted Hand Therapy in Patients With Spinal Cord Injury

July 19, 2023 updated by: Sevda Adar, Afyonkarahisar Health Sciences University

The Effect of Robot Assisted Hand Therapy on Hand Functions and Quality of Life in Patients With Spinal Cord Injury: A Randomized Controlled Study

Considering the scarcity of studies on robotic hand therapy, it has been seen that larger-scale and long-term follow-up studies are needed. In this study, our aim is to compare the effects of robot-assisted hand therapy and conventional physiotherapy on hand functions and quality of life in patients with spinal cord injury.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Spinal cord injury (SCI) is considered one of the most devastating injuries that cause lifelong disability.Among the impaired functions, upper extremity function is one of the most important goals of rehabilitation for these individuals.Hand functions are among the most important determinants of independence.Some studies have reported that in more than half of people with tetraplegia, restoring arm and hand function will improve quality of life.Therefore, small improvements in upper extremity function can make a clinically significant difference in feeding, bathing, transferring and other functional activities.Given that the majority of individuals with spinal cord injuries are in their most productive years and life expectancy approaches that of the healthy population, more aggressive treatment strategies that focus on improving peripheral muscle control and recovery of the central nervous system (CNS) are needed.Recently, treatment based on the 'motor learning theory' has been reported to be effective in the recovery of impaired upper extremity function.It has been shown that by repetitive movements as intense as possible to help achieve the ultimate goal of optimum movement, patients are able to learn motor skills that lead to CNS recovery.It has also been suggested that repetitive and activity-based exercise may facilitate recovery after spinal cord injury by inducing practice-dependent brain and spinal cord plasticity.Therefore, repetitive, intensive, and activity-based upper extremity rehabilitative therapy can help improve impaired upper extremity function.In this context, robotic therapy (RT) may be an alternative way of delivering rehabilitative therapy to patients with tetraplegia, as RT can deliver consistently high-intensity, high-repetition, and task-specific training with less effort compared to conventional therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Afyonkarahisar, Turkey, 5325940725
        • Sevda Adar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Mini mental test score >15
  • Able to understand the commands
  • Had a function between 1 and 4 in at least one of the key muscle strengths in at least one hand.

Exclusion Criteria:

  • Patients with persistent pain in the upper extremity (VAS>40)
  • Patients with severe spasticity in the hand (MAS≥3)
  • Patients with severe limitation of joint range of motion / contracture in the hand
  • Patients who had fractures or operations in the upper extremity in the last 6 months
  • Patients who received botulinum toxin injection to the upper extremity in the last 6 months
  • Patients with skin ulcers
  • Patients with severe visual impairment and severe depression
  • Patients who cannot sit in a chair for more than 30 minutes
  • Patients with a history of stroke or progressive neurodegenerative disease
  • Patients with neuromuscular disease
  • Patients with uncontrolled epilepsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Robot Assisted Therapy Group
In the RAT group, it was planned to perform robotic rehabilitation with a hand-finger robot [Amadeo (Tyromotion, Graz, Austria)] for 30 minutes for both upper extremities, accompanied by a physiotherapist who is trained in robotic rehabilitation and has at least 5 years of experience. In robotic rehabilitation, continuous passive range of motion (CPM), active assistive exercises and assistive continuous passive range of motion (CPM Plus) programs will be used.
Procedure: Robot Assisted Therapy
In robotic rehabilitation, continuous passive range of motion (CPM), active assistive exercises and assistive continuous passive range of motion (CPM Plus) programs will be used.
Procedure: Conventional Therapy
In the Conventional Therapy group, an exercise program consisting of passive and active assistive range of motion exercises, strengthening exercises and task-oriented exercises for 30 minutes for both hands was planned, accompanied by a physiotherapist experienced in spinal cord injury rehabilitation for at least 5 years.
Active Comparator: Conventional Therapy Group
In the Conventional Therapy group, an exercise program consisting of passive and active assistive range of motion exercises, strengthening exercises and task-oriented exercises for 30 minutes for both hands was planned, accompanied by a physiotherapist experienced in spinal cord injury rehabilitation for at least 5 years.
Procedure: Conventional Therapy
In the Conventional Therapy group, an exercise program consisting of passive and active assistive range of motion exercises, strengthening exercises and task-oriented exercises for 30 minutes for both hands was planned, accompanied by a physiotherapist experienced in spinal cord injury rehabilitation for at least 5 years.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
American spinal cord injury association impairment scale
Time Frame: 15 minutes
The ASIA Evaluation determines the level of injury in patients with spinal cord injury (SCI) based on the levels of sensory, motor, and neurologic injury. Neurological injury level (NLI): NLI refers to the most caudal segment of the spinal cord with normal sensory and antigravity motor function on both sides of the body, provided there is normal (integrated) sensory and motor function rostrally.
15 minutes
Sollerman hand function test
Time Frame: 60 minutes
It consists of 20 different activities based on eight basic hand grips (pulp grip, lateral pinch, triple pinch, 5-finger pinch, diagonal volar grip, transverse volar grip, spherical volar grip, extension type grip). It also evaluates functional properties. Scoring of activities was done in the range of 0-4, according to the completion time of the activity. Failure to perform the activity 0, if it is performed in 60 seconds 1, if it is completed between 60-41 seconds or not with the desired grip pattern 2, if it is completed between 21-40 seconds and there is a minimum deviation in the grip pattern 3, if it is completed within 20 seconds with the specified grip pattern 4 points evaluated.The scoring rules were chosen so that subjects with normal hand function would achieve 80 points. As the score increases, the success rate of the test increases.
60 minutes
Nine Hole Peg Test
Time Frame: 20 minutes
This test measures dexterity based on performance (in seconds). A wooden board with nine holes on it, 9 short wooden sticks and a box in which the wooden sticks can be placed are placed in front of the patient. Using the hand to be evaluated, the patient is asked to place the wooden sticks in the box into the holes on the panel as quickly as possible. Then, he is asked to put the sticks back into the box one by one. The completion time of the test is determined by a stopwatch. In this test, which evaluates manual dexterity based on performance, the success rate increases as the time gets shorter.
20 minutes
Box and block test
Time Frame: 30 minutes
It is used to evaluate rough manual dexterity based on performance (time). 150 small wooden cubes are filled from the box with the patient's hand to be tested into the adjacent box. The patient is asked to throw one cube at a time into the semi-empty box. How many cubes are thrown in 60 seconds is counted. The result gives the score. How many cubes are thrown in 60 seconds is counted. The result gives the score. The higher the score, the higher the success rate.
30 minutes
Jamar pinchmeter
Time Frame: 5 minutes
The hand grip strength of the participants will be measured with the 'Jamar Hand Dynamometer'. Measurements will be made with the shoulder adjacent to the trunk in adduction and neutral rotation, elbow 90 degrees flexed, wrist 0-30 degrees dorsiflexion and 0-15 degrees ulnar deviation with thumbs up. In the dominant and non-dominant hands, the measurements will be repeated three times (first right, then left and again right, etc.) with an interval of 5 seconds, and the average of the three measurements will be recorded in kilograms. The higher the score, the higher the success rate.
5 minutes
Jamar hand dynamometer
Time Frame: 5 minutes
Finger grip strength will be evaluated with a 'Jamar digital pinchmeter'. Patients will be placed in a sitting position with the wrist in 90° flexion and the forearm in a neutral position. Measurements will be made bilaterally in three different positions as lateral, palmar and fingertip grips. Patients will be asked to squeeze with maximum force and each measurement will be made three times, and their averages will be recorded in kg.The higher the score, the higher the success rate
5 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Spinal cord injury independence scale
Time Frame: 15 minutes
It is a test that determines the functional status in spinal cord injury. It is evaluated between 0-100 points. It consists of 17 items in total. This scale consists of self-care, respiratory-sphincter control and mobility subsections. : It is evaluated between 0-100 points. The higher the score, the higher the success rate.
15 minutes
Modified Ashworth Scale
Time Frame: 10 minutes
In MAS, patients are evaluated over 5 points. 0; there is no increase in muscle tone, and 4 indicates that the extremity is rigid in the direction of flexion and extension.
10 minutes
Functional Independence Scale
Time Frame: 15 minutes
It is a scale that evaluates the performance of individuals regarding activities of daily living. It consists of 18 items and evaluates the functions of individuals in 2 main sections: physical/motor function (13 items) and cognitive function (5 items). The items also include 6 subheadings (self-care, sphincter control,transfers, movement, communication, and social-perception).Each item is scored between 1-7; 1 indicates full assistance and 7 indicates complete independence. The total score ranges between 18-126 (fully dependent-fully independent).
15 minutes
Short form 36
Time Frame: 15 minutes
This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health. Total score was between 0 ( disability) and 100 (no disability). Every subgroup of the questionnaire has a score scale between 0 and 100 Every increase in the subgroup of SF-36 questionnaire, which is a positive scoring system, indicates increase in quality of life related to health.Total score was between 0 ( disability) and 100 (no disability).
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Afyonkarahisar Health Sciences University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SEVDA ADAR, Afyonkarahisar Health Sciences University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SATETRA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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